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62 device results listed.

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D-0270127VL

Gonorrhoe Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: möLab GmbH
Manufacturer SRN: DE-MF-000022941
UDI-DI: D-0270127VL
Basic UDI-DI: B-0270127VL
Reference: 0270127
EMDN: W0105010201
EMDN description: GONOCOCCAL ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 05.07.2026 16:24

Manufacturer products View details

ResistancePlus GC(610)

1.0

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000238
Basic UDI-DI: 9352224020110WC
Reference: 2011025
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Neisseria gonorrhoeae

Aptima Neisseria gonorrhoeae Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505421
Basic UDI-DI: 54200455DIAGAPTGCQL
Reference: 302927
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260030

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260030
Basic UDI-DI: 122000026NATERCK5
Reference: NATNG-6MC-IVD
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 01.07.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

TaqPath™ Menu | GeneProof™ Neisseria gonorrhoeae PCR Kit

GeneProof Neisseria gonorrhoeae PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304027
Basic UDI-DI: 859569630025QH
Reference: A58124
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:59

Manufacturer products View details

GeneProof Neisseria gonorrhoeae PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300388
Basic UDI-DI: 859569630025QH
Reference: NG/GP/100
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:59

Manufacturer products View details

GeneProof Neisseria gonorrhoeae PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300371
Basic UDI-DI: 859569630025QH
Reference: NG/GP/025
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:58

Manufacturer products View details

06972412611782

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611782
Basic UDI-DI: 697241261IGO-502D6
Reference: IGO-502
EMDN: W0105010201
EMDN description: GONOCOCCAL ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Neisseria gonorrhoeae

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505438
Basic UDI-DI: 54200455DIAGAPTGCQL
Reference: 302927
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

06955792730793

Neisseria Gonorrhoeae DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730793
Basic UDI-DI: B-06955792730793
Reference: S3003E
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria Gonorrhoeae DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730786
Basic UDI-DI: B-06955792730786
Reference: S3003E
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Gonorrhea Rapid Test

GON-S23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817664
Basic UDI-DI: B-06952804817664
Reference: GON-S23
EMDN: W0105010202
EMDN description: GONOCOCCAL ANTIBODY ASSAYS TOTAL
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus GC(550)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000276
Basic UDI-DI: 9352224020110WC
Reference: 2013001
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 25.06.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus GC (550)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000245
Basic UDI-DI: 9352224020110WC
Reference: 2013025
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 25.06.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus GC (610)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000269
Basic UDI-DI: 9352224020110WC
Reference: 2011001
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 25.06.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus GC (675)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000283
Basic UDI-DI: 9352224020110WC
Reference: 2015001
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 25.06.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus GC (675)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000252
Basic UDI-DI: 9352224020110WC
Reference: 2015025
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 25.06.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus GC Controls

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000306
Basic UDI-DI: 9352224020110WC
Reference: 95003
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 25.06.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus GC (7500)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224001457
Basic UDI-DI: 9352224020110WC
Reference: 99009
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 25.06.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

ResistancePlus GC (LC480)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224001440
Basic UDI-DI: 9352224020110WC
Reference: 99010
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 25.06.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details